Naldemedine previously demonstrated its efficacy in Phase 3 clinical trials (COMPOSE program) in patients with OIC. The proposed indication for naldemedine in the U.S. is for the treatment of OIC in adult patients with chronic non-cancer pain.

OIC is characterized by reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency after initiating opioid therapy.